Enzalutamide Impurity 68 CAS CATO-C4X-101668

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-101668
Molecular FormulaC12H16N2O3
Molecular Weight236.27 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Enzalutamide Impurity 68 CAS CATO-C4X-101668 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Enzalutamide Impurity 68.

As a process- or degradation-related impurity, Enzalutamide Impurity 68 (CAS CATO-C4X-101668, C12H16N2O3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage, Enzalutamide Impurity 68 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 236.27 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.

CATO manufactures Enzalutamide Impurity 68 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

Molecular FormulaC12H16N2O3
Molecular Weight236.27 g/mol
AppearanceOff-white to pale yellow crystalline powder
Purity≥95%
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)6.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms2

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